A Review of Regulations, Terminology, and Practical Approaches to Reportable Range Verification

被引：1

作者：

Xiao, Yi ^{[1
]}

Chambliss, Allison B. ^{[2
]}

机构：

[1] Childrens Hosp Los Angeles, Dept Pathol, Lab Med, Los Angeles, CA USA

[2] UCLA, Dept Pathol, Lab Med, David Geffen Sch Med, Los Angeles, CA 90095 USA

来源：

JOURNAL OF APPLIED LABORATORY MEDICINE | 2023年 / 8卷 / 04期

关键词：

LINEARITY;

D O I：

10.1093/jalm/jfad001

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

Background In the United States, federal regulations under CLIA '88 require reportable range verification of quantitative assays used for clinical purposes. Some accreditation agencies and other standards development organizations have their own additional requirements, recommendations, and/or terminologies relating to reportable range verification, leading to varying practices among clinical laboratories. Content Requirements and recommendations related to reportable range or analytical measurement range verification from different organizations are reviewed and compared. Optimal approaches to materials selection, data analysis, and troubleshooting are collated. This review clarifies key concepts and outlines various practical approaches to reportable range verification.

引用

页码：773 / 788

页数：16

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